Roxadustat FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 21, 2020.
FDA Approved: No
Generic name: roxadustat
Company: FibroGen, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development for the treatment of anemia of chronic kidney disease (CKD).
Development Timeline for roxadustat
|Apr 6, 2021||FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021|
|Mar 1, 2021||Further Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease|
|Mar 1, 2021||FibroGen Provides Regulatory Update on Roxadustat|
|Dec 18, 2020||Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease|
|Feb 11, 2020||FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease|
|Dec 23, 2019||FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease|
|Nov 7, 2019||Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients with Anemia in Phase III OLYMPUS and ROCKIES Trials|
|Sep 26, 2019||FibroGen Announces Initiation of Phase 2 Clinical Trial of Roxadustat for the Treatment of Anemia in Cancer Patients Receiving Chemotherapy|
|May 14, 2019||Pooled Analyses of the Roxadustat Global Phase III Programme Confirmed Cardiovascular Safety|
|Dec 20, 2018||Phase III OLYMPUS and ROCKIES Trials for Roxadustat Met Their Primary Endpoints in Chronic Kidney Disease Patients with Anemia|
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